Manager, Computer Systems Validation (CSV)
$160,600–$189,000 year
On-siteRedwood City, California, United States
Job Summary
Manage day-to-day operations for IT Compliance and Risk Management by providing assessment, review, and oversight of Enterprise and GXP computer systems validation. Develop validation strategies, author validation documents including master plans and protocols, and ensure compliance and the validated state of all GXP systems. Provide validation guidance on data migration activities, approve GXP system changes, and develop test support for proposed changes in development environments. Coordinate vendor support release activities and manage external CSV consultants while serving as the interface between IT and QA. Support cross-functional groups with GXP system implementation projects, including enhancements, releases, and revalidation, ensuring risks are identified and mitigated.
Required Qualifications
- 8+ years' experience in QA or Validation performing protocol review and approval associated with the implementation and maintenance of computerized systems in pharma/biotech environment
- Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 210, 211& 11, Annex 11, GAMP5, ICH Q9, Data Integrity, CSA
- Thorough understanding of validation/qualification and concepts as it applies to pharmaceutical quality systems
- Proficiency with Veeva QualityDocs / QMS and ComplianceWire
- Experience with CTMS and Regulatory systems
- Ability to manage external software and consultant vendors
- Applicants must be currently authorized to work in the United States on a full-time basis
Desired Qualifications
- Excellent communication skills with the ability to effectively communicate across organizational levels and functions
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